We help biopharmaceutical, emerging biotech and medical device companies develop products, get them to the market, and grow their impact through the life cycle in a more effective, efficient, and modern way. We bring together healthcare domain expertise, fit-for-purpose technology, and an agile operating model to provide a diverse range of solutions. These aim to deliver, amongst other outcomes, a personalized, scalable and omnichannel experience for patients and physicians. It’s what drives our team and our purpose to enable healthcare organizations to be future ready.
Post : Lead – Scientific Writing
Job Description
Role Purpose : Manage a team; direct, develop and review various regulatory deliverables & dossiers; ensure quality as per set HA standards.
Principal Responsibilities :
Thorough knowledge of EU, MENA and ASEAN markets country requirements/regulatory affairs procedures for initial submission, licensing, post-approval submission management
Solid project management, organizational and time management skills to manage
Client-specific project delivery process
Strong analytical skills and problem-solving skills
Excellent knowledge on various regulatory guidelines related to Dossier Preparation & Regulatory Submission for EU, MENA and ASEAN markets in ACTD, eCTD and non-eCTD format [e.g., NDA/BLA/INDs, MAAs]
Provides guidance to project teams related to worldwide HA submission structure/format/requirements, submission filing strategy, eCTD document lifecycle management and submission compilation workflows
Co-ordinate with relevant cross functional group Regulatory Affairs, CMC, Submission Managers and Medical Writing to obtain accurate, appropriate information for regulatory submission
Develops, completes, and maintains submission delivery plans, submission content plans, and proactively provides status updates to designated collaborators.
Assist in the preparation and submission of post-approval regulatory filings, variations, and renewal applications
Review regulatory dossier preparation and submission like new drug application, variations, renewals, site registration etc.
Conduct gap analysis to identify compliance issues and implement corrective actions to align with regulatory requirements.
Review the content prepared by junior team members. Validate the authenticity of the content by performing QC of the dossier prepared
Responsible for high client satisfaction for all regulatory submission deliverables with regard to quality and accuracy, timelines, and efforts
Performing RCA when required with the team and preparing CAPA
Prepare the company for regulatory inspections and audits, including mock audits and readiness assessments.
Conducting regular client calls for content-related discussions as well as for project status updates and delivery
Participate in trainings and learn through hands-on experience on the job
Participate in client-specific training if applicable
Mentoring of new joiners with respect to SOPs and processes
Understand various target audience and methods to approach different deliverables
Candidate Profile
EDUCATION : BPharm / MPharm/ Pharm D/ MSc
EXPERIENCE : Required 6-8 years of experience in EU, MENA and ASEAN markets
Skills :
Dossier Preparation (eCTD, ACTD and CTD)
Good communication skills (Written and Oral)
MS Office (Excel and Power point), Adobe Professional
Desirable to have hands on experience on RIMS preferably Veeva Vault, Trackwise
Additional Information
Qualification : BPharm, MPharm, Pharm.D, MSc
Experience : 6-8 years
Location : Bangalore, KA
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Scientific Writing
End Date : 25th September 2024
